# K033213: Codent Dental Air-Powered Handpiece, Model HPS

- Pathway: 510(k) (Traditional)
- Applicant: Codent Technical Industry Co., Ltd.
- Decided: Feb 6, 2004 after 126 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935676 (1995). 1 ancestor in all.
36 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935676: Micro RSH High Speed Handpiece, Micro Motors, Inc. (1995) Summary page 1.

## Most influential descendants
- K052822: Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 (2006), 35 descendants of its own
- K062740: Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU (2006), 21 descendants of its own
- K062812: Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N (2006), 20 descendants of its own
- K101717: Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H Coupling (2010), 17 descendants of its own
- K112024: TI-Max X450 (2012), 16 descendants of its own

## Indications for use
CODENT Dental Air-Powered Handpiece, model HPS is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth. CODENT Dental Air-Powered Handpiece carries the following label: CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Source page: https://510kreport.com/device/K033213
Methodology: https://510kreport.com/methodology